JKM
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Immunochemical, Bence-Jones Protein
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5150
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CAPILLARYS URINE (K080916) | Sebia | 2008-07-01 |
| CAPILLARYS URINE (PN 2012) (K070486) | Sebia, Inc. | 2007-12-21 |
| PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT (K050119) | Beckman Coulter, Inc. | 2005-05-06 |
| HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT (K972591) | Morax | 1998-03-04 |
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Every clearance here is in the API, with alerts when new ones post.